Validation of software of machines and equipment related to production process
Need to validate the software of machines and equipment related to the production process and not to the product.
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Yes, you need to validate software of machine and equipment related to the production process, but only when there is a new revision of the software; when you get information from the machine manufacturer that there is a necessity to update the software.
If that is not the case, then you do not need to regularly validate that software.
You can see how records of software validation look in ISO 13485:2016 Documentation toolkit on the following link:
- Record of Software Validation https://advisera.com/13485academy/documentation/record-of-software-validation-iso-13485-2016/
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Oct 05, 2020